{"id":10381,"date":"2022-08-18T08:53:42","date_gmt":"2022-08-18T15:53:42","guid":{"rendered":"https:\/\/www.qad.com\/blog\/?p=10381"},"modified":"2023-06-07T14:29:04","modified_gmt":"2023-06-07T21:29:04","slug":"drug-supply-chain-security-act-overview","status":"publish","type":"post","link":"https:\/\/www.qad.com\/blog\/2022\/08\/drug-supply-chain-security-act-overview","title":{"rendered":"Drug Supply Chain Security Act (DSCSA) Overview: Are You Ready?"},"content":{"rendered":"

[vc_row][vc_column][vc_single_image image=”10383″ img_size=”full”][vc_column_text]Pharmaceutical manufacturers and their supply, contract packaging and distribution partners are under constant pressure to comply with government requirements while maintaining high standards for patient safety, product quality and innovation.<\/span><\/p>\n

A lack of traceability in the drug supply chain is a barrier to progress in all of these areas, but the US Food and Drug Administration (FDA) is working to change that through the Drug Supply Chain Security Act (DSCSA). The DSCSA, which takes full effect in November 2023, should usher in a new era of supply chain resilience for the US pharmaceutical industry, but compliance is not without its challenges.<\/span><\/p>\n

A 2017 survey from KPMG found <\/span>45% of companies<\/span><\/a> had already invested upwards of $50 million in IT and technological infrastructure to support compliance. Many of those efforts, however, took a backseat during the pandemic. Existing vulnerabilities in the global supply chain were brought to the surface and companies had to act fast to minimize disruption.<\/span><\/p>\n

Many of the supply chain risks that companies are grappling with today mirror the challenges the FDA is hoping to solve with the DSCSA. The same infrastructure required for compliance could also help companies address other major supply chain and operational concerns, but November 2023 is coming up fast and companies need to start preparing now.\u00a0<\/span><\/p>\n

What is the Drug Supply Chain Security Act (DSCSA)?<\/span><\/h2>\n

A lack of <\/span>traceability<\/span><\/a> in the drug supply chain is a problem for companies as much as it is for consumers and the FDA. Congress in November 2013 moved to strengthen this supply chain through the enactment of the Drug Supply Chain Security Act, which is part of the Drug Quality and Security Act (DQSA).<\/span><\/p>\n

The DSCSA, as <\/span>defined<\/span><\/a> by the FDA, \u201coutlines steps to achieve interoperable, electronic tracing of products at the lot, unit, and now package level to identify and trace certain prescription drugs as they are distributed in the United States.\u201d<\/span><\/p>\n

\u201cThis will enhance the FDA\u2019s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. These requirements will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.\u201d<\/span><\/p>\n

Regulatory jargon aside, the DSCSA was created to accomplish three goals over its 10-year implementation. Those goals are as follows:<\/span><\/p>\n